On September 16, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled "Material and Method for Treating Cancer (Press release, UroGen Pharma, SEP 16, 2024, View Source [SID1234646663])."
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The allowed claims relate to the combination of UroGen’s RTGel technology with medac’s licensed proprietary lyophilized mitomycin formulation and cover the use of UroGen’s UGN-103 and UGN-104 development programs in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. The U.S. patent, once issued, will have an expiration date in December 2041.
"Allowance of this patent application strengthens our intellectual property position for our next-generation investigational programs for patients with urothelial cancers," said Liz Barrett, President and CEO of UroGen. "We believe that the combination of UroGen’s RTGel technology with medac’s patent-protected lyophilized mitomycin has the potential to provide advantages related to production, cost, supply, and product convenience for patients. Our vision remains to develop innovative medicines that advance the care of patients, and this patent allowance is a key element of our strategy to build a long-term growth company."
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for LG-IR-NMIBC and UGN-104 for LG-UTUC. In April 2024, the FDA accepted UroGen’s IND application for UGN-103 and the company is currently onboarding clinical sites for the study. The company anticipates commencing a similar study for UGN-104, which is expected in early 2025.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission for UGN-102 in August 2024, ahead of schedule. UroGen anticipates potential FDA approval in early 2025 if the NDA is accepted for filing by the FDA and priority review is granted.
About UGN-103 and UGN-104
UGN-103 and UGN-104 are innovative mitomycin formulations in development by UroGen for the treatment of LG-IR-NMIBC and LG-UTUC, respectively. UGN-103 aims to streamline manufacturing and reconstitution processes while providing intellectual property coverage until December 2041; it utilizes UroGen’s RTGel technology for prolonged mitomycin exposure. UGN-104, also leveraging RTGel technology, is designed for treating low-grade upper tract urothelial cancer and is anticipated to enter Phase 3 trials in early 2025, offering a non-surgical treatment option with similar intellectual property protection.